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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

FDA Moves to Reduce Backlog of ANDAs

The US Food and Drug Administration (FDA) is moving to clear a massive backlog of abbreviated new drug applications (ANDAs), used by companies looking to market generic versions of FDA-approved products, in advance of new resources expected under a duo of user fee bills expected to be passed by the Congress within the next few months.

In a 13 June Federal Register posting, the agency said it wants to disregard any ANDA which it deems to have been abandoned by virtue of it being both incomplete and its sponsors not having been in contact with the agency since July 1991. FDA said no fewer than 364 ANDAs meet this definition of abandonment.

While the agency said it currently has statutory authority to deem as "voluntarily withdrawn" any application issued a complete response letter (CRL) for which it has not received a response within a year of the issuance of the CRL, the 364 applications in question pre-date FDA's authority and are not subject to the same regulations.

"If the applicant wishes to actively pursue approval of an Inactive ANDA and does not wish the application to be deemed by FDA to have been voluntarily withdrawn, the applicant must inform the Agency," explained FDA. Conversely, applicants may also agree to have their applications withdrawn at an even earlier time by notifying the Office of Generic Drugs.

As FDA Law Blog notes, FDA's backlog of ANDAs has nearly tripled in the last six years as a combination of patent expirations and resource shortages have created a perfect storm of both more applications and comparatively fewer resources with which to review them. The ANDA backlog was approximately 1,000 in January 2006. By May 2012, the backlog was more than 2,800 strong.

The elimination of the 364 applications would reduce the backlog by more than 13%, but is unlikely to have any real effect on other applications pending review.

Explains FDA Law Blog, the effort appears to be "phase one in the agency's efforts to do some house cleaning in anticipation of the enactment and implementation of The Generic Drug User Fee Act (GDUFA)and to develop a master list of backlog ANDAs," which can then be used to track progress under GDUFA.